Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis Contributes medical input for country/site selection, feasibility assessment and engage in KOL interaction Prepare charters and coordinate internal/external committee meetings including presentation preparation (ie, Dose Escalation Committee, DMC, Steering Committee, and Safety Committees) Participate in the development and review of study plans and serve as a liaison to project teams and CROs Provide input for the development of publications in coordination with Scientific Communications Contribute to training at Investigator meetings, CRO/CRA training, SIVs as warranted Qualifications PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline Minimum of 6 years of experience in clinical research with at least 3 or more years of drug development experience Prior oncology/hematology drug development experience is a plus Proven skills from working in a project oriented matrixed team environment Excellent oral, written and interpersonal (communication) skills Ability to travel, as needed This role is located in Princeton NJ and is hybrid. Responsibilities Lead or co-lead one or more clinical trial(s) in a therapeutic area for one or more compounds Works closely with Medical Director and other Sr. level Clinical Research Scientist (as warranted) Contributes to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP) In collaboration with the Medical Director, contributes to the development of clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] to support registration and commercialization of the compound(s) Participates in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g.